Job Description Summary
Provides manufacturing engineering and technical support to manufacturing, cost reduction and product development projects. This includes equipment and process development, validations, and troubleshooting. Performs various engineering assignments that support Sotera’s objectives. Assignments require the investigation of several variables.
- Applies engineering principles in managing, supporting, and maintaining the production of new and existing products and implementation of design changes and product improvements.
- Plans, schedules, conducts, and coordinates detailed phases of the engineering project or work as part of a major project.
- Performs independently on most assignments with instructions as to the general results expected. Documents work and reviews progress and results with manager.
- Designs and develops production processes, fixturing and equipment.
- Develops test protocols, conducts testing and writes reports for products and manufacturing equipment and processes validation.
- Identifies the root cause of manufacturability yield and specification issues, implements corrective actions for those relating to design, and communicates findings to other team members or to those responsible for other types of issues.
- Interfaces with Manufacturing, Quality, Marketing, R&D, and/or supplier to resolve manufacturing, quality, equipment, product design, and/or component issues so as to meet company’s objectives.
- Works cross functionally with Manufacturing, Quality, Engineering, and R&D to establish project requirements, planning, analysis, implementation and progress.
- Implements product quality and process improvement programs.
- Communicates well orally and in writing. Able to present ideas and proposals to all levels of the organization.
- Generates engineering documentation (specifications, risks analysis, drawings, reports, protocols, revisions, etc.).
- Participates in design reviews. Communicates with applicable resources to assess manufacturing feasibility and potential issues of product changes and new products.
- Reviews and signs quality records and engineering documents as applicable.
- Implements cost reduction and margin improvement programs.
- Complies with applicable safety rules and recommendations.
- May be assigned to supervise other personnel.
- Complies with and ensures that subordinates, contract employees, and suppliers comply with Sotera’s Quality System requirements and standards agencies.
- Performs other assignments as directed.
Education and Experience Requirements
- Bachelor's degree in Engineering or related field.
- Minimum of 8 years of Manufacturing/Sustaining engineering experience.
- Minimum of 3 years of medical device experience.
Skills and Knowledge
- Working knowledge of equipment process and validations.
- Proficient in SolidWorks and Microsoft Office Applications (Microsoft Word, Excel and PowerPoint).
- Experience working in an ISO/FDA regulated industry and manufacturing environment preferred.
- Experience in writing and maintaining technical documentation.
Local candidates only. Sotera Wireless will not sponsor applicants for work visas.
Sotera Wireless, Inc. is a San Diego, California based health technology company dedicated to detecting early signs of patient deterioration in any acute care setting. Our goal is to help hospitals to improve patient safety across the enterprise with minimum impact to the alarm burden, clinical workflow, or technical support. If we can help nurses detect patient deterioration early enough, further complications can be avoided. The Sotera team includes leaders in patient monitoring technology as well as and clinical leaders that understand the challenges of introducing technology and practice change into hospitals.
Role: Sr. Manufacturing Engineer
Location: San Diego,
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